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FDA gives Cue Health first EUA for at-home, OTC COVID-19 molecular testing

At-home COVID-19 testing kit by Brisbane company Ellume approved for use in the United States

But so far, there are no plans to approve the tests for use in Australia. It has been a lot of work from many hundreds of people over a decade, and a terrific team effort to get to this point…it is very rewarding, Ellume founder and CEO Dr Sean Parsons told Today. The company had been working on developing a test for the flu when they changed tact to deal with the coronavirus, he said. We were able to take that core technology and spin that into a COVID test pretty quickly. The technology was well advanced, and we were able to get the first at-home test, non-prescription, through the FDA, with an emergency use authorisation.

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